31 lug - Roma
Iqvia
ppAs a bPrincipal Biostatistician /b, you will provide strategic statistical leadership for bOncology clinical trials /b, with a particular focus on bhematological malignancies /b including bmultiple myeloma, leukemia, and lymphoma /b. You will work closely with cross-functional teams to deliver high-quality statistical support across the clinical development lifecycle, ensuring compliance with regulatory and industry standards. /p h3Key Responsibilities /h3 ul liProvide Principal-level Biostatistics leadership for Oncology clinical development programs and studies /li liLead and contribute to statistical activities across clinical trials, acting as the primary statistical representative on assigned studies /li liReview and provide quality control oversight of SDTM datasets and associated deliverables, ensuring compliance with CDISC standards /li liCollaborate closely with Statistical Programming, Data Management, Clinical Operations, and Regulatory teams to ensure accurate and timely delivery of statistical outputs /li liSupport the interpretation and communication of study results to cross-functional stakeholders /li liEnsure all statistical deliverables meet quality, regulatory, and timeline expectations /li liEffectively communicate statistical concepts, analyses, and recommendations to both technical and non-technical audiences /li liContribute to study design discussions, protocol development, and statistical methodology as required /li /ul h3Candidate Requirements /h3 ul liAdvanced experience as a Principal Biostatistician within a Pharmaceutical, Biotechnology, or CRO environment /li liStrong experience within Oncology clinical development /li liDemonstrated expertise in hematological malignancies,
including multiple myeloma, leukemia, and/or lymphoma /li liStrong knowledge and practical application of CDISC standards, including SDTM /li liExperience performing or overseeing QC of SDTM datasets and related outputs /li liProven ability to work effectively within cross-functional teams and influence key stakeholders /li liExcellent verbal and written communication skills /li liStrong understanding of statistical principles and clinical trial methodology /li /ul h3Preferred Qualifications /h3 ul liExperience serving as Lead Study Statistician within a cross-functional clinical development team /li liKnowledge and experience in clinical trial statistical design and study planning /li liExperience supporting regulatory submissions and interactions with health authorities pIQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at /p pIQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism. /p /li /ul /p #J-18808-Ljbffr
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